The present invention relates to a method and apparatus for treating a number of ailments for example, colds, asthma and certain other skin infections such as herpes, athletes foot and other viral or fungal skin infection and also relates to a method and apparatus for the delivery of medicants.
The common cold has persisted as an ailment affecting the human species since the earliest days of man. While great advances have been made over the years in dealing with numerous diseases, the common cold has endured as a persistent ailment which has heretofore defied effective treatment.
Recently it has been found that the common cold is caused by a virus. Additional research has uncovered the fact that a cold can be caused by in excess of one hundred different viruses and occasionally by bacteria. Thus the reason for the elusiveness of an effective cold remedy becomes apparent.
Cold viruses seem to find the temperature within the nose, about 33.degree. C. or 91.4.degree. F., more agreeable than the warmer climate of the blood and internal organs. The viruses attack the cells of the mucous membrane, producing congestion, sneezing and nasal drip. Some viruses have other effects, including aches, fever, coughing and chill. Colds take two to three days to incubate and last a week or so to run their course, declining slowly from an early peak. Sufferers are most infectious at the beginning, when sneezing and dripping are at their height. The virus kills the nasal cells it infects, and it takes time to regenerate them. That is one explanation of why it may take a while to recover from a cold.
For most adults, a cold is merely a nuisance. Sometimes it requires a day or two of bed rest, but more often it affects the victim with severe discomfort exemplified by a tired achey feeling. Children, however, often run a fever--and one adult cold virus, known as respiratory syncytial virus, can cause severe illness and even death in infants. Colds can also threaten adults suffering from chronic asthma and bronchitis.
The economic effect of colds is not negligible. The National Center for Health Statistics estimates that Americans caught 93 million colds--a rate of about 41.4 per 100--in 1981. But this total includes only cases that led to a visit to a doctor or restricted activity, 105 million days of bed disability and 32 million days off work. In 1979 (the most recent year for which figures are available), there were 11 deaths in which acute nasopharyngitis was listed as the sole cause of death.
Most viruses give immunity afterward, but only to that one virus. That is why small children seem to go from one cold to another, year round since their immunities are not in place. Adults tend to catch fewer colds year by year as acquired immunities build up.
Infuriating as it seems, after the decades of research into the complex of conditions called the common cold, there are still no useful suggestions for the ordinary sufferer. Once the cold has set in, the only treatment is to relieve symptoms.
Like all viruses, the ones that cause colds consist of a bit of genetic material, RNA or DNA, the two acids that constitute the genetic code, wrapped in a coat of protein. When the virus attacks the cell, the genetic chemicals enter the cell, then shed the coat. There they feed on the cell's genetic core, diverting it from its real function in the body and ordering it to build more viruses, which then leave the cell and repeat the cycle.
A cure for a cold presumably would have to invade the cell as well, destroying the virus without harming the cell.
Because it has been found that the cold virus exists predominately in the nasal passages where the temperature is lower, at 91.4.degree. F., than other body areas, it has been reasoned that by artificially heating the nasal passages above 98.6.degree. F., the cold virus might be killed or seriously weakened. The present invention applies earlier research into the uses of hyperthermia for various other human ailments to the problems of cold virus. Hyperthermia as it is used in this disclosure, and generally, has come to mean temperatures in humans above 41.degree. C. or 106.degree. F. induced with therapeutic intent.
Hyperthermia has shown various therapeutic advantages for a variety of ailments. More recently physical hyperthermia has been introduced to treat malignant cells in cancer therapy. Of significance, it is now assumed that some cancers are caused by viruses and changes in the genetic structure of the affected cells. In addition, it has been found that hyperthermia often shows synergism with X-irradiation and chemotherapy making combination therapy attractive. It has also been established that in general, malignant cells are more sensitive than normal cells in the range of 41.degree. C. to 44.degree. C., or 106.degree. F. to 111.degree. F. Medical researchers around the world report that heating malignant tissue to the hyperthermic range appears to be a safe and efficient means for either destroying the cancer cells or making them more susceptible to other forms of treatment. It has also been found by cancer researchers that immunal responses are stimulated by the application of controlled heat to the malignant areas. Controlled heat also increases the circulation of blood to the affected area, aiding in the carrying away of dead cell material as well as the rebuilding of new cells.
In developing the present invention, original experiments utilized only the application of heat of approximately 100.degree. F. to 105.degree. F. to the nasal passages. These experiments showed that cold symptoms, while not lasting the full seven to ten day cycle, were only reduced to a four to five day cycle. Greater effectiveness at this heat range may have been demonstrated by much longer exposure to the heat source, but convenience and tolerance especially among children were significant limiting factors. Experiments then continued with higher heat levels, 110.degree. F. up to 150.degree. F., which produced better results than the lower levels but cold symptoms still lingered. The experiments continued with various temperature levels in combination with various microbicidal agents including hexylresorcinol and povidone-iodine. It was found that higher temperatures, which heated the nasal passages to approximately 106.degree. F. to 140.degree. F., in combination with the microbicidal agents hexylresorcinol and/or povidone-iodine resulted in cold symptoms disappearing within twelve to thirty-six hours.
It is believed that the combination treatment works best because the heated air seriously weakens the cold viruses and the concurrent or immediate introduction of the microbicidal agents further attacks the now weakened viruses, or occasionally bacteria, leading to their effective neutralization. The weakening or killing of the virus also acts as a catalyst to the body's immune system. The heat also increases the blood to the nasal passages, aiding in carrying away the dead cells and regenerating the new healthy cells in the nasal passages. Thus it was found that the treatment of early cold symptoms with heat and either hexylresorcinol or povidone-iodine, or both, usually resulted in their complete prevention or elimination within hours at most.
For fully developed colds, a combination of heat plus the microbicidal antiviral agents hexylresorcinol and/or povidone-iodine proved most effective, with elimination of symptoms within twelve to thirty-six hours. As used herein the term microbicidal agent means a germicide or antiseptic which, when applied in the nasal passages and used in conjunction with the application of heat to the nasal passages, produces an alleviation of cold symptoms in a cold sufferer. It is believed that the combination of the application of the microbicidal agent with hyperthermia treatment produces a significantly greater antiviral action.
The preferred choice of microbicidal agents, povidone-iodine and hexylresorcinol, was dictated by their demonstrated effectiveness in combination with the hyperthermia treatments. In addition both povidone-iodine and hexylresorcinol have proven to be effective while being non-toxic and non-irritating to the body or mucous membranes, after more than twenty-five years of use by the general public.
The leading povidone-iodine agent is sold under the trademark "Betadine" and this was the formulation used in the development of one aspect of this invention. Povidone-iodine is a highly effective, broad spectrum topical microbicide for antiseptic use on skin, wounds and mucosa. It is employed widely in the hospital, clinic, office and home. Povidone-iodine differs physically and chemically from all other typical antiseptics and iodophors and is recognized as the only non-detergent iodophor presenting properties different from those of other germicidal iodine compounds or solubilized iodine mixtures. Povidone-iodine provides the following advantages: microbicidal activity, not merely bacteriostatic; broad spectrum microbicidal activity to kill both grim-positive and gram-negative bacteria (including antibiotic-resistant strains), tubercle bacillus, fungi, viruses, protozoa and yeasts; fast acting killing of most pathogens (except spores) within one minute in vitro with many organisms killed in only 15 to 30 seconds; microbicidal activity is maintained in the presence of blood, pus, serum and mucosal secretions; and virtually nonirritating and nonstinging to skin and mucus.
Hexylresorcinol was chosen due to its broad spectrum microbicide properties, low toxicity and soothing qualities. Development of the present invention has indicated effectiveness against the cold virus when used in combination with hyperthermia in preventing colds and in treating and eliminating existing cold symptoms.
In studies at Johns Hopkins Hospital published in the Bulletin of Johns Hopkins Hospital 41:21, 1927, Hexylresorcinol in a 1:1000 concentration in a glycerine-acqueous solution was shown to be completely effective against the common pathogenic bacteria including:
______________________________________ Test Organisms Control 15 Seconds ______________________________________ ESCHERICHIA COLI + 0 EBERTHELLA TYPHOSA + 0 PSEUDOMONAS PYOCYANEUS + 0 PROTEUS VULGARIS + 0 STAPHYLOCOCCUS ALBUS + 0 STAPHYLOCOCCUS AUREUS + 0 CORYNEBACTERIUM DIPHTHERIAE + 0 CORYNEBACTERIUM HOFMANNI + 0 STREPTOCOCCUS HAEMOLYTICUS + 0 STREPTOCOCCUS VIRIDANS + 0 PNEUMOCOCCUS TYPE I + 0 PNEUMOCOCCUS TYPE IV + 0 NEISSERIA MENINGITIDIS + 0 NEISSERIA GONORRHOEAE + 0 VIBRIO METCHNIKOVII + 0 ______________________________________ + = Growth 0 = Sterile
Over the years hexylresorcinol has shown to have antimicrobicidal effects and has also been used as a gargle and a urinary antiseptic. It has been shown to be effective as a urinary antiseptic in killing microbes in the urine in concentrations ranging from 1:60,000 to 1:18,000. Other germicidal studies have shown effectiveness in dilutions as high as 1:5000. In the development of the present invention hexylresorcinol in dilutions of 1:2000 in a glycerine-acqueous solution were used and occasionally dilutions of 1:1000 were also used.
Other applications for hexylresorcinol over the years have included application for cuts, abrasions, burns, sunburns, athletes foot and the hygienic care of the mouth as a mouthwash, gargle and application after tooth extraction. Hexylresorcinol is also used as the active ingredient in a leading throat lozenge.
According to the Federal Register, Volume 47, no. 101, May 25, 1982, a panel commissioned by the Federal Drug Administration found hexylresorcinol in concentrations at least as high as 1:1000 to be safe for topical applications to the mucous membranes of the mouth and throat.
Many medicants become more efficacious when heated. Therefore among the advantages of the method and apparatus of the present invention is the potential use of lower dosages of a given medicant at higher than room or body temperatures. Temperatures used may exceed body temperatures by 2.degree. F. up to a level of 180.degree. F., depending upon the limitations of a particular medicant as evidenced by boiling point, evaporation or chemical change.
In addition the localized hyperthermia provided by use of the present invention increases blood flow, thus increasing absorption both topically and into the body from the point of application. Local hyperthermia also increases EP or Endogenous Pyrogen and T-cell production, a vital defense of the immune system. Recent studies by Gordon Duff and Scott Durham at Yale University have shown that T-cell production increases as much as twenty fold when the tissue temperature is raised from 98.6.degree. F. to 102.2.degree. F. These studies also show that elevated temperature strengthens the effect of the anti-viral agent interferon, which is more than three times as effective in combatting virus infections in tissue cultures when the temperature is raised from 102.2.degree. F. to 104.degree. F. In addition an increase in EP helps the body to withhold iron from the infecting bacteria. When combined synergistically with medicines strengthened by the elevated temperatures, it is evident that the present invention provides advantages in combating various infections and disease by providing a unique medicant delivery system.
Various prior art devices have been proposed for the treatment of respiratory or infectious problems. The Stuart device, U.S. Pat. No. 1,239,634, produces a flow of warmed air to the patient but not at hyperthermia levels. However, the Stuart device will not be effective against colds as the amount of heat produced is virtually unregulated and not sufficiently high enough. This differs substantially from the invention disclosed herein which produces controlled heated air to take advantage of the properties of hyperthermia. The Stuart device, using the disclosed filter, produces a very unmeasured amount of medicant as there is no way of controlling how much medicant is released from the medicated cotton over a given period of time.
The Mascolo device, U.S. Pat. No. 1,965,424, utilizes steam passing through a closed cup of medicant. Again this device fails to present a means of controlling the temperature of the steam which is probably dangerously high, especially for children. The towel disclosed therein purportedly protects the face from the boiling steam, but again it is difficult to ascertain the amount of thermal protection and the amount of medicant being delivered to the face and to the nasal passages, if any.
The Inoue device, U.S. Pat. No. 2,047,324, provides for the delivery of volatile matters or medicinal matters fumigated by means of an electric heating device and a forced draft. Again the device provides no control as to the amount of heat or the amount of medicant provided to the user.
The Conlin device, U.S. Pat. No. 3,522,236, provides a means of delivering vapors, perhaps medicated, to the user with a crude means of temperature control. Again the amount of medicant and the temperature range of the vapors are difficult to carefully regulate.
Specifically, such previous apparatus do not incorporate controlled conditions of temperature or medicant delivery which is important to the efficacy of an effective cold treatment procedure and especially in the safe treatment of the patient, and none disclose a way of stopping the medicant without shutting down the entire device.
Additionally, such previous apparatus have not specifically recognized the advantages of combining hyperthermia with any specific microbicides for the treatment of the common cold. More specifically none disclose or teach the advantages of either hexylresorcinol or povidone-iodine in their treatment, nor do they appear to provide an especially convenient means of treatment in terms of comfort or time with these obvious advantages. These noted prior art devices are also bulky, barely portable and certainly not lightweight and handheld as is the device of the present invention with its obvious advantages particularly in treating another patient.
It is therefore an object of the present invention to provide a method and apparatus to provide an effective treatment to alleviate the symptoms of the common cold in a cold sufferer.
It is a further object of the present invention to provide a simple yet effective method and apparatus to treat symptoms of the common cold through the use of hyperthermia by warming the nasal passages of the cold sufferer and then providing for the application of a microbicidal agent within the nasal passages.
A still further object of the present invention is to provide an apparatus for the treatment of the common cold which effectively combines the ability to heat the nasal passages of a cold sufferer to hyperthermic levels and to selectively deliver a microbicidal agent in convenient dosage to the warmed nasal passages.
Yet another object of the present invention is to provide such apparatus in a simple to construct, lightweight form which is conveniently handheld so as to be relatively simple and easy to use.
A still further object of the present invention is to provide such apparatus wherein a selected microbicidal agent may be dispensed in a controlled quantity so as to effectively provide a convenient dosage of the selected medicant.
Yet another object of the present invention is to provide an apparatus to deliver a variety of medicants for topical or internal use especially in instances where the mucous membranes may effectively and expeditiously absorb the prescribed medicant.
Yet another object of the present invention is to provide an apparatus to deliver a variety of medicants for topical or internal use as a method of treatment. In topical uses the device provides localized controlled and regulated hyperthermia as well as controlled and regulated medicant delivery to open lesions from such infections as herpes, acne, athletes foot and jock itch as illustrative examples.